Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2010-0025
2. Registrant Information.
Registrant Reference Number: 080127642
Registrant Name (Full Legal Name no abbreviations): Wellmark International
Address: 100 Stone Road West, Suite 111
City: Guelph
Prov / State: Ontario
Country: Canada
Postal Code: N1G5L3
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
14-NOV-08
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
14-NOV-08
Product Description
7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.
Active(s)
PMRA Registration No. 26493
PMRA Submission No.
EPA Registration No.
Product Name: Zodiac Fleatrol Power Spot Flea and Tick Control for Dogs Over 14 kg
- Active Ingredient(s)
- (S)-METHOPRENE
- PERMETHRIN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
2
Units: mL
10. Site pesticide was applied to (select all that apply).
Site: Animal / Usage sur un animal domestique
11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).
The owner inappropriately applied the product to the cat to treat a flea infestation.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
No
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Cat / Chat
3. Breed
Domestic Shorthair
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
0.16
7. Weight (provide a range if necessary )
5
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
>2 hrs <=8 hrs / > 2 h < = 8 h
11. List all symptoms
System
- Nervous and Muscular Systems
- Symptom - Other
- Specify - Ear Twitching
12. How long did the symptoms last?
>2 hrs <=8 hrs / > 2 h < = 8 h
13. Was medical treatment provided? Provide details in question 17.
No
14. a) Was the animal hospitalized?
No
14. b) How long was the animal hospitalized?
Unknown
15. Outcome of the incident
Fully Recovered / Complètement rétabli
16. How was the animal exposed?
Treatment / Traitement
17. Provide any additional details about the incident
(eg. description of the frequency and severity of the symptoms
On November 13, 2008 the owner rinsed the application site with warm water until she could no longer smell the product. The APSS veterinarian recommended that the owner take the cat to the veterinarian and have the veterinarian call for information. When the veterinarian called APSS, the APSS veterinarian recommended the following: bathe the cat with liquid dish detergent, monitor body temperature, give methocarbamol if needed for full body tremors, run a chemistry panel to monitor electrolytes and renal values, monitor closely, provide symptomatic and supportive care, and call back with questions.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here
The pet was monitored at the veterinarian and made a full recovery on November 14, 2008. This product was not used according to label directions, do not use on cats.